FDA — authorised 15 December 2006
- Application: NDA021592
- Marketing authorisation holder: NOVARTIS
- Local brand name: FORADIL CERTIHALER
- Indication: POWDER — INHALATION
- Status: approved
🇺🇸 Perforomist, nebulization, COPD in United States
FDA authorised Perforomist, nebulization, COPD on 15 December 2006
Marketing authorisations
FDA — authorised 22 June 2021
- Application: ANDA091141
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 25 November 2022
- Application: ANDA216486
- Marketing authorisation holder: RITEDOSE CORP
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 December 2022
- Application: ANDA215621
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 March 2023
- Application: ANDA215883
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 26 June 2024
- Application: ANDA218304
- Marketing authorisation holder: MICRO LABS
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 October 2024
- Application: ANDA216426
- Marketing authorisation holder: LEXENPHARM
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 11 February 2025
- Application: ANDA218308
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: FORMOTEROL FUMARATE
- Indication: SOLUTION — INHALATION
- Status: approved
Other Respiratory approved in United States
Frequently asked questions
Is Perforomist, nebulization, COPD approved in United States?
Yes. FDA authorised it on 15 December 2006; FDA authorised it on 22 June 2021; FDA authorised it on 25 November 2022.
Who is the marketing authorisation holder for Perforomist, nebulization, COPD in United States?
NOVARTIS holds the US marketing authorisation.